Duke University
The QA Regulatory and Compliance Associate supports the Marcus Center for Cellular Cures' GMP lab by ensuring compliance with FDA regulations and FACT accreditation standards for cellular and tissue-based therapies. The role involves managing deviations, investigations, and CAPAs, as well as collaborating with quality systems and manufacturing teams to maintain regulatory adherence. This position requires expertise in bioprocess development and cGMP production to facilitate the transition from process development to clinical trials and commercial manufacture.
Duke University is a private research university in Durham, North Carolina, offering rigorous undergraduate, graduate, and professional programs. It houses prominent schools of medicine, nursing, engineering, law, business, and public policy alongside Duke Health and multiple research institutes that translate discovery into clinical care and industry partnerships. Duke emphasizes interdisciplinary scholarship, global engagement, and innovation across the sciences, arts, and humanities, attracting selective students and faculty from around the world. Its Research Triangle location fosters collaboration with nearby universities, hospitals, and technology companies.
Headquarters
San Francisco, CA
Company Size
201-500 employees
Founded
2018
Industry
Technology
Glassdoor Rating
4.2 / 5
Sarah Johnson
Chief Executive Officer
Michael Chen
Chief Technology Officer
Emily Williams
VP of Engineering
David Rodriguez
VP of Product
Jessica Thompson
Chief Financial Officer
Andrew Park
VP of Sales
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and employee contacts for Duke University.